Catalog Number

LNGC2022YX

Brand Name

Needle Guide

Version/Model Number

LNGC2022YX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FZX

Product Code Name

Guide, Surgical, Instrument

Public Device Record Key

f9a4f145-0af1-4dcb-9449-bb86a3cf7d79

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Package DI Number

20886333001679

Quantity per Package

20

Contains DI Package

00886333001675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box